Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06221631

BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis

The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nerve Degeneration Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location status: Recruiting

About this study

After being informed about the study, healthy controls and patients with multiple sclerosis giving written informed consent will undergo blood examination (for determination of the biological age using the publicly available R-package algorithm BioAge), clinical examination (for motor, cognitive and psychological parameters) as well as an MRI-investigation with chemical exchange saturation transfer (CEST) and T1-relaxometry on a 7 Tesla MRI. Data from the healthy controls will be used to set up a normative brain age data set, that could be used for example to train a model for brain age prediction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Informed Consent signed by the subject

  • Group 1: Any healthy individual between 18 and 65 years of age
  • Group 2: Any individuals with any diagnosis of Multiple Sclerosis between 18 and 65 years of age and EDSS ≤6.0.

Exclusion criteria

  • Group 1 and 2: Any other neurological disease except primary headaches: insufficient language skills in German or French; pregnancy, lactation, any contraindication for MRI (active implants, passive ferromagnetic implants, passive non-ferromagnetic metallic implants >4cm in the region covered by the active RF coils, large tattoos inside a region covered by the active radiofrequency (RF) coils, claustrophobia or suspected/known non-compliance), smoking within the last 10 years prior recruitment, any other drug consumption except moderate alcohol intake (less than a standard drink containing 10 grams of alcohol per day) or use of medical cannabis, any previous head trauma (with known/suspected intracranial consequences), Body Mass Index (BMI) >30, and any other chronic progressive disease.
  • Specific Criteria for group 1: The calculated biological age (BioAge R Package algorithm) differs by > -8/+1 years from the chronological age. These patients will not be further invited for a study visit with clinical examination and MRI.
  • Specific Criteria for group 2: EDSS > 6.0 as this impacts physical testing; clinical relapse within the last 6 months

Treatment and study plan

Primary outcomes

  1. Brain Age Gap in patients with MS

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Difference between estimated brain age and (A) biological as well as (B) chronological age.

Secondary outcomes

  1. Relationship of brain age gaps with disease severity

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with disease severity as measured by the expanded disability and severity scale (EDSS; min.-max. according to eligibility criteria: 0-6 points, with a higher score meaning a higher degree of disease severity)

  2. Relationship of brain age gaps with gait speed

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with gait speed as measured by the 25-foot walking test

  3. Relationship of brain age gaps with upper extremity function

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with upper extremity function as measured by the 9-hole Peg Test

  4. Relationship of brain age gaps with sitting-to-raise time

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with a raising test using the sitting-to-raise time

  5. Relationship of brain age gaps with cognitive symptoms

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with cognitive (brief international cognitive assessment in multiple sclerosis (BICAMS))

  6. Relationship of brain age gaps with depression symptoms

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with depression symptoms as assessed with the brief depression inventory (BDI)

  7. Relationship of brain age gaps with fatigue

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with fatigue as assessed with the fatigue severity score (FSS)

  8. Relationship of brain age gaps with quality of life

    Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

    Relationship of brain age gaps with experienced quality of life as assessed with the Multiple Sclerosis Impact Scale (MSIS)-29

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Schweizerische Multiple Sklerose Gesellschaft
  • University of Bern

Registry information

Official study title

Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)

Acronym: BrainAgeMS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 24, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.